# K983110: Flexart,Flexart/Hyper, Visart, Visart/Hyper

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Feb 25, 1999 after 174 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903768 (1990). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970573: Flexart V3.5 Software, Toshiba America Mri, Inc. (1997) Summary page 2.
- K965068: Magnetic Resonanc Dvce Visart V 3.5 Software, Toshiba America Medical Systems, In.C (1997) Summary page 2.
- K973799: Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact, Siemens Medical Solutions USA, Inc. (1998) Summary page 2.
- K962138: Flexart V3.1 Software, Toshiba America Mri, Inc. (1996) Summary page 2.

## Most influential descendants
- K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon (2000), 1 descendant of its own
- K023207: Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit) (2002), 0 descendants of its own

## Indications for use
imaging of: - The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.] - Fluid Visualization - 2D/3D Imaging - MR Angiography/MR Vascular Imaging - Blood Oxygenation Level Dependent (BOLD) Imaging

Source page: https://510kreport.com/device/K983110
Methodology: https://510kreport.com/methodology